A medical device domain analysis model based on HL7 RIM

Clinical investigations (CIs) are carried out to demonstrate safety and efficacy of new Medical Devices (MDs). The presence of many stakeholders participating in CIs makes it necessary to develop a common standard language to achieve semantic interoperability among systems and organizations. In Italy the National Research Council is carrying out a project supported by Ministry of Health aiming to develop an information system (MEDIS) that manages MD clinical investigations. In order to develop a flexible and interoperable system, MEDIS design has been based on the application of HL7 (Health Level 7) v.3 standards. This paper presents the results of the MEDIS design: the MD DAM based on HL7 RIM. © 2009 European Federation for Medical Informatics.